AMIODARONE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMIODARONE HYDROCHLORIDE (UNII: 976728SY6Z) (AMIODARONE - UNII:N3RQ532IUT)

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

AMIODARONE HYDROCHLORIDE

Composition:

AMIODARONE HYDROCHLORIDE 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Because of its life-threatening side effects and the substantial management difficulties associated with its use (see WARNINGS   below), amiodarone hydrochloride tablets are indicated only for the treatment of the following documented, life-threatening recurrent ventricular arrhythmias when these have not responded to documented adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated. 1. Recurrent ventricular fibrillation. 2. Recurrent hemodynamically unstable ventricular tachycardia. As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of amiodarone hydrochloride tablets favorably affects survival. Amiodarone hydrochloride tablets should be used only by physicians familiar with and with access to (directly or through referral) the use of all available modalities for treating recurrent life-threatening ventricular arrhythmias, and who have access to appropriate monitoring facilities, including in-hospital and ambul

Product summary:

Amiodarone Hydrochloride Tablets, for oral administration are available as 200 mg Round, flat-faced, beveled edge, yellow tablets debossed “ E” over bisect, “144” below bisect, plain on the reverse side and supplied as: NDC 0615-4545-39 Blistercards of 30 NDC 0615-4545-05 Blistercards of 15 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure as required. Protect from light. KEEP TIGHTLY CLOSED. This product’s label may have been updated. For current full prescribing information, please visit www.us.sandoz.com or call our customer service department toll-free at 1-800-525-8747. Distributed by Sandoz Inc. Princeton, NJ 08540 46061724 Rev. June 2016 MF0144REV06/16

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET
NCS HealthCare of KY, Inc dba Vangard Labs
----------
MEDICATION GUIDE
Amiodarone Hydrochloride Tablets
(am-ee-OH-dah-rohn)
Read the Medication Guide that comes with Amiodarone Hydrochloride
Tablets before you start taking them
and each time you get a refill. There may be new information. This
Medication Guide does not take the place
of talking with your doctor about your medical condition or your
treatment.
What is the most important information I should know about Amiodarone
Hydrochloride Tablets?
Amiodarone Hydrochloride Tablets can cause serious side effects that
can lead to death including:
•
lung damage
•
liver damage
•
worse heartbeat problems
•
thyroid problems
Call your doctor or get medical help right away if you have any of the
following symptoms during treatment
with amiodarone hydrochloride tablets:
•
shortness of breath, wheezing, or any other trouble breathing;
coughing, chest pain or spitting up of
blood
•
nausea or vomiting, brown or dark-colored urine, feel more tired than
usual, yellowing of your skin or
the whites of your eyes (jaundice), or right upper stomach pain
•
heart pounding, skipping a beat, beating fast or very slowly, feel
light-headed or faint
•
weakness, weight loss or weight gain, heat or cold intolerance, hair
thinning, sweating, changes in
your menses, swelling of your neck (goiter), nervousness,
irritability, restlessness, decreased
concentration, depression in the elderly, or tremor.
Amiodarone Hydrochloride Tablets should only be used in people with
life-threatening heartbeat problems
called ventricular arrhythmias, for which other treatments did not
work or were not tolerated.
Amiodarone Hydrochloride Tablets can cause other serious side effects.
See “What are the possible side
effects of Amiodarone Hydrochloride Tablets?” If you get serious
side effects during treatment you may need
to stop Amiodarone Hydrochloride Tablets, have your dose changed, or
get medical treatment. Talk with
your doctor b

Summary of Product characteristics

AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
AMIODARONE HYDROCHLORIDE TABLETS
RX ONLY
DESCRIPTION
Amiodarone hydrochloride tablets are a member of a new class of
antiarrhythmic drugs with
predominantly Class III (Vaughan Williams’ classification) effects,
available for oral administration as
yellow, scored tablets. Each tablet for oral administration contains
200 mg of amiodarone
hydrochloride. In addition, each tablet contains the following
inactive ingredients: colloidal silicon
dioxide, corn starch, lactose monohydrate, magnesium stearate,
povidone, and D&C yellow No. 10
aluminum lake. Amiodarone hydrochloride tablets are a benzofuran
derivative: 2-butyl-3-benzofuranyl
4-[2-(diethylamino)-ethoxy]-3,5-diiodophenyl ketone hydrochloride.
The structural formula is as follows:
C
H I NO • HCl Molecular Weight: 681.8
Amiodarone hydrochloride is a white to cream-colored crystalline
powder. It is slightly soluble in
water, soluble in alcohol, and freely soluble in chloroform. It
contains 37.3% iodine by weight.
CLINICAL PHARMACOLOGY
ELECTROPHYSIOLOGY/MECHANISMS OF ACTION
In animals, amiodarone hydrochloride is effective in the prevention or
suppression of experimentally
induced arrhythmias. The antiarrhythmic effect of amiodarone
hydrochloride may be due to at least two
major properties:
1. a prolongation of the myocardial cell-action potential duration and
refractory period and
2. non-competitive antagonism of α- and β-adrenoceptors.
Amiodarone hydrochloride prolongs the duration of the action potential
of all cardiac fibers while
causing minimal reduction of dV/dt (maximal upstroke velocity of the
action potential). The refractory
period is prolonged in all cardiac tissues. Amiodarone hydrochloride
increases the cardiac refractory
period without influencing resting membrane potential, except in
automatic cells where the slope of the
prepotential is reduced, generally reducing automaticity. These
electrophysiologic effects are
reflected in a decr